NDC 10370-195

levetiracetam extended-release

Levetiracetam

levetiracetam extended-release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Levetiracetam.

Product ID10370-195_a46e7248-dd69-4781-98a2-e08646630304
NDC10370-195
Product TypeHuman Prescription Drug
Proprietary Namelevetiracetam extended-release
Generic NameLevetiracetam
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-10-04
Marketing CategoryANDA / ANDA
Application NumberANDA091360
Labeler NamePar Pharmaceutical, Inc.
Substance NameLEVETIRACETAM
Active Ingredient Strength500 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10370-195-06

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-195-06)
Marketing Start Date2011-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10370-195-09 [10370019509]

levetiracetam extended-release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091360
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-04

NDC 10370-195-50 [10370019550]

levetiracetam extended-release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091360
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-04

NDC 10370-195-06 [10370019506]

levetiracetam extended-release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091360
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-04

Drug Details

Active Ingredients

IngredientStrength
LEVETIRACETAM500 mg/1

OpenFDA Data

SPL SET ID:64a585fa-d55a-4851-a4bf-1be55b3067d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 807832
  • 846378

    • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    Medicade Reported Pricing

    10370019506 LEVETIRACETAM ER 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "levetiracetam extended-release" or generic name "Levetiracetam"

    NDCBrand NameGeneric Name
    10370-195levetiracetam extended-releaselevetiracetam extended-release
    10370-214levetiracetam extended-releaselevetiracetam extended-release
    35208-031Levetiracetam Extended-releaseLevetiracetam Extended-release
    35208-032Levetiracetam Extended-releaseLevetiracetam Extended-release
    40051-079LEVETIRACETAM Extended-releaseLEVETIRACETAM Extended-release
    40051-332LEVETIRACETAM Extended-releaseLEVETIRACETAM Extended-release
    52817-111levetiracetam extended-releaselevetiracetam extended-release
    52817-110levetiracetam extended-releaselevetiracetam extended-release
    60429-349Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    60429-350Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    50228-190Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    50228-189Levetiracetam Extended-ReleaseLevetiracetam Extended-Release
    55488-0519LEVETIRACETAM Extended-releaseLEVETIRACETAM Extended-release
    0054-0224LevetiracetamLevetiracetam
    0121-0799LevetiracetamLEVETIRACETAM
    0121-1598LevetiracetamLEVETIRACETAM
    0121-2397LevetiracetamLEVETIRACETAM
    0121-4799LevetiracetamLEVETIRACETAM
    0121-4802LEVETIRACETAMLEVETIRACETAM
    0143-9574LevetiracetamLevetiracetam
    0143-9673LevetiracetamLevetiracetam
    0228-2167LevetiracetamLevetiracetam
    0378-5613Levetiracetamlevetiracetam
    0378-5615Levetiracetamlevetiracetam
    0378-5617Levetiracetamlevetiracetam
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